NCT04209920

Brief Summary

It is a randomized clinical trial in which two different types of full coverage restoration in used to restore hypomineralized first permanent molar and protect the remaining tooth structure in patients with molar incisor hypomineralization ,one group is covered with CAD-CAM milled poly methyl methacrylate crowns and the other group is covered with cast metal copings (CAC) using nickel chromium alloy and there will be a nine months follow up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

September 8, 2019

Last Update Submit

September 6, 2023

Conditions

Molar Incisor Hypomineralization

Keywords

Molar Incisor HypomineralizationMIHHypomineralizedFirst permanent molarMolar defectsPMMAcast adhesive coping

Outcome Measures

Primary Outcomes (5)

  • Marginal Integrity

    the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.

    9 months follow up

  • Related quality of life: questionnaire

    A questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort.

    9 months

  • Recurrent caries

    the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.

    9 months

  • Gingival Health

    the gingival health around the crown is evaluated using Gingival Index (GI) by a periodontal probe and clinical sign of inflammation .

    9 months

  • longevity

    longevity of the crown is measured by the presence of the crown in the oral cavity cemented and sound.

    9 months

Study Arms (2)

PMMA crown Group

ACTIVE COMPARATOR

Hypomineralized first permanent molars in patients with molar incisor hypomineralization.

Device: CAD-CAM milled PMMA crown

Cast metal coping Group

ACTIVE COMPARATOR

Hypomineralized first permanent molars in patients with molar incisor hypomineralization.

Other: Cast metal coping using nickel chromium alloy

Interventions

CAD-CAM milled PMMA crownDEVICE

the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using PMMA disks using a CAD-CAM technology.

PMMA crown Group
Cast metal coping using nickel chromium alloyOTHER

the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using Nickel Chromium alloy to make a Cast Coping.

Cast metal coping Group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patient with molar incisor hypomineralization having at least one permanent fist molar affected and indicated for full coverage.
  • Patient is healthy and medically free.
  • Patient's age range from 6 to 12 years old.
  • The molar is free from any symptoms of pulp inflammation or has reversible pulpitis (Hypersensitivity).

You may not qualify if:

  • Patient who has any chronic systemic disease or immunocompromised.
  • Patient with special health care needs.
  • Molar which has irreversible pulpitis or pulp necrosis.
  • Molar which has periapical radiolucency and/or abscess or fistula or any periapical pathosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant at MSA university

Study Record Dates

First Submitted

September 8, 2019

First Posted

December 24, 2019

Study Start

March 1, 2019

Primary Completion

January 1, 2021

Study Completion

April 1, 2021

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)